Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: internal connecting means in claim 1, interpreted as “an internal screw thread” or “clamps, locks, friction fitting, snap fit beads,” Specification Par. 0042.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10 and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites “a pair of….irrigation ports.” How do these relate to the previously cited at least one irrigation port? It is assumed that this is intended to modify and refer to the same.
Claim 15 recites “an irrigation fluid passageway surrounding an exterior surface of said cannula and said sheath portion.” It is unclear how the fluid passageway surrounds both an exterior surface of the cannula and surrounds the sheath portion, in the typical use of “surrounds.” For the purposes of examination, and in line with the specification [e.g. Fig. 8], “surrounding…said sheath portion” is taken to be surrounding the interior surface of the sheath portion. However, clarification is requested.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 6-10, 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hong [US 20080167604 A1].
Re. claim 1, Hong discloses: An ophthalmic surgical apparatus [Fig. 2], said apparatus comprising:
a hollow terminal portion [119] defining an internal passage [interior of 119] communicating with at least one aspiration port [120] in said terminal portion to permit fluid communication through said terminal portion [Par. 0017];
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a hollow sheath portion [114] extending along a central axis from said terminal portion [Fig. 2], said sheath portion defining at least one irrigation port [132], said sheath portion defining a first external diameter in a direction perpendicular to said central axis [The diameter of sheath 114, Fig. 2]; and
a flaring, hollow hub portion [Annotated Fig. 3] extending from said sheath portion, said hub portion defining an open proximal end for receiving an instrument [112] operatively connected to an irrigation fluid source and/or a vacuum source [the instrument is not a positively recited part of the claim, nor are the irrigation/vacuum sources; but these are taught in Hong], said hub portion defining internal connecting means [internal threading, Fig. 3, see 112(f) interpretation above] to secure said hub portion around the instrument [Fig. 3], said hub portion defining a second external diameter in a direction perpendicular to said central axis that is greater than said first external diameter of said sheath portion [Fig. 2].
Re. claim 2, Hong discloses: The ophthalmic surgical apparatus in accordance with claim 1 in combination with an instrument in the form of a cannula [112] operably connected to a handpiece [140, Fig. 4] operatively connected to a vacuum source [Par. 0017] and an irrigation fluid source [Par. 0017].
Re. claim 6, Hong discloses said hub portion has a frustoconical upper end [Annotated Fig. 2] connecting to said sheath portion [Fig. 2].
Re. claim 7, Hong discloses said connecting means is an internal thread within said hub portion [Fig. 3].
Re. claim 8, Hong discloses the apparatus set forth above including the terminal and sheath and hub portions being unitarily [Figs. 3-4] formed of a polymer [Par. 0008].
Re claim 9. Hong discloses the polymer being an elastomer [Par. 0008].
Re. claim 10, Hong discloses said sheath portion includes a pair of oppositely-facing irrigation ports [132, Fig. 2].
Re. claim 15, as best understood, Hong discloses a method of using a surgical apparatus, said method comprising the steps of: obtaining the surgical apparatus according to claim 1 [as set forth with respect to claim 1 above]; assembling said apparatus with a cannula [112. The step of assembling is inherent because the structure was at some point assembled] operably connected to a handpiece [140] operatively connected to a vacuum source and/or an irrigation fluid source [both, Par. 0017] to establish an aspiration passageway through said terminal portion and an interior of said cannula [136] and an irrigation fluid passageway [130] surrounding an exterior surface of said cannula and said sheath portion [ “surrounding…said sheath portion” is taken to be surrounding the entire interior surface of the sheath portion]; aspirating material at a surgical site through said aspiration passageway [Par. 0017]; and introducing an irrigation fluid to a surgical site through said irrigation fluid passageway [Par. 0017].
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hong.
Re. claim 3, Hong discloses: The ophthalmic surgical apparatus in accordance with claim 2, wherein said cannula is rigid, to establish an aspiration passageway through said terminal portion and an interior of said cannula [interior of 112], said sheath portion is spaced from an exterior surface of said cannula to establish an irrigation fluid passageway surrounding said cannula [Fig. 2, Par. 0017], the cannula [112, Fig. 2] seals against an internal surface in said terminal portion [Fig. 2, Par. 0008], sheath portion is formed from a polymer [elastomeric sleeve, Par. 0008, where the sleeve refers to 114, equivalent to the sheath in Blake].
Hong fails to explicitly disclose the cannula being formed of metal, but discloses it being “relatively rigid” [Par. 0008]. Furthermore, Hong states that the prior art uses a metal cannula [Par. 0006]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Hong by using metal for the cannula material because this amounts to a simple substitution of one material suitable in the art for another with predictable results.
Claim(s) 4-5, 11-12, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hong in view of Nallakrishnan et al. [US 2016/0374854 A1, hereinafter “Nallakrishnan.”].
Re. claim 4, Hong discloses the apparatus set forth above but fails to teach the terminal portion having a substantially spherical shape. However, Nallakrishnan teaches, in an ophthalmic surgical apparatus, the terminal portion[20] has a substantially spherical shape [24, Par. 0040, Figs. 1-2] defining a third external diameter in a direction perpendicular to said central axis that is greater than said first external diameter of said sheath portion [Fig. 1 shows the diameter of spherical portion 24 being greater than that of 12]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Hong by adding, to the terminal portion of Blake, a spherical tip (having an aspiration port) because this shape “presents a softer surface with no angles to lessen the possibility of injury to the capsule” [Nallakrishnan Par. 0009].
Re. claim 5, Hong discloses the apparatus set forth above but fails to teach the terminal portion having a substantially spherical shape. However, Nallakrishnan teaches, in an ophthalmic surgical apparatus, the terminal portion[20] has a substantially spherical shape [24, Par. 0040, Figs. 1-2]defining a third external diameter in a direction perpendicular to said central axis that is less than said second external diameter of said hub portion [Fig. 2]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Hong by adding, to the terminal portion of Blake, a spherical tip (having an aspiration port) because this shape “presents a softer surface with no angles to lessen the possibility of injury to the capsule” [Nallakrishnan Par. 0009].
Re. claim 11, Hong discloses the apparatus set forth above but fails to teach said at least one aspiration port is angled between about 40 degrees and about 50 degrees relative to said central axis. Nallakrishnan teaches said at least one aspiration port is angled between about 40 degrees and about 50 degrees relative to said central axis [Par. 0044]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Hong to have the claimed angle between the aspiration port and central axis in order to allow a degree of maneuverability to allow the tip to aspirate particles without removing and reorienting the apparatus [Nallakrishnan Par. 0044].
Re. claim 12, Hong discloses the apparatus set forth above but fails to teach said terminal portion defines an outer surface that is relatively rougher. However, Nallakrishnan teaches a terminal portion defines an outer surface that is relatively rougher than an outer surface of said sheath portion [Fig. 9, Par. 0049]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Hong to form the terminal portion to be rougher than an outer surface of the sheath portion as taught by Nallakrishnan in order to provide a suitably tacky surface [Nallakrishnan Par. 0049].
Re. claim 14, Hong discloses the apparatus set forth above but fails to teach terminal portion further comprises an annular internal abutment. However, Nallakrishnan teaches said terminal portion further comprises an annular internal abutment [131] extending into said internal passage and spaced from a terminal end surface of said terminal portion [Fig. 8]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Hong by adding an annular internal abutment as taught by Nallakrishnan in order to allow engagement with a mating annular retention step of the aspiration cannula [Nallakrishnan Par. 0047].
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hong in view of Walter [US 20130231605 A1].
Re. claim 13, Hong discloses the apparatus set forth above but fails to teach the recess, protrusion, or indicia on the terminal portion. However, Walter teaches, in an ophthalmic surgical device, said terminal portion defines at least one recess, protrusion, and/or indicia [protrusion 26f] therein (“for indicating the location of said at least one aspiration port” refers to the intended use of the above, not given further patentable weight). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Hong by adding a protrusion to the terminal portion in order to indicate the separation between the terminal portion and the irrigation ports.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Blake [US Pat. 4573979].
Re. claim 1, Blake discloses: An ophthalmic surgical apparatus [Fig. 2], said apparatus comprising:
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a hollow terminal portion [26] defining an internal passage [interior of 26] communicating with at least one aspiration port [open end of 26, Annotated Fig. 2] in said terminal portion to permit fluid communication through said terminal portion [Col. 4 lines 57-62];
a hollow sheath portion [16] extending along a central axis from said terminal portion [Fig. 2], said sheath portion defining at least one irrigation port [18a/b], said sheath portion defining a first external diameter in a direction perpendicular to said central axis [Annotated Fig. 1]; and
a flaring, hollow hub portion [28] extending from said sheath portion, said hub portion defining an open proximal end for receiving an instrument [10] operatively connected to an irrigation fluid source and/or a vacuum source [the instrument is not a positively recited part of the claim, nor are the irrigation/vacuum sources; but these are taught in Blake], said hub portion defining internal connecting means [internal threading 34, see 112(f) interpretation above] to secure said hub portion around the instrument [10, Fig. 1], said hub portion defining a second external diameter in a direction perpendicular to said central axis that is greater than said first external diameter of said sheath portion [Annotated Fig. 1].
Blake discloses features of certain other dependent claims as well.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-Th 9 am to 3 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACKIE HO can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771
